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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cuff, Tracheal Tube, Inflatable
510(k) Number K902114
Device Name CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR
Applicant
Diemolding Corp.
125 Rasbach St.
Canastota,  NY  13032
Applicant Contact JEAN WALLACE
Correspondent
Diemolding Corp.
125 Rasbach St.
Canastota,  NY  13032
Correspondent Contact JEAN WALLACE
Regulation Number868.5750
Classification Product Code
BSK  
Date Received05/11/1990
Decision Date 07/18/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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